510(k) K133483
- Device
- PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
- Applicant
- PORTABLE THERAPEUTIX
- 510(k) number
- K133483
- Product code
- IRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-11
- Date received
- 2013-11-13
- Regulation
- 890.5650
- Classification name
- Massager, Powered Inflatable Tube
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharyn Orton, Ph.D.
- Address
- 2001 Honor Ave. Ashland MA US 01721 01721
FDA Registration Numbers#
- 3004006265
- 1000548922
- 3029083714
- 3014737458
- 3014159202
- 3007778244
- 1832894
- 3015619973
- 3013440654
- 3011491271
- 3033530347
- 3027500264
- 3033648890
- 3032062344
- 3021282523
- 3003619590
- 3017643003
- 3038295706
- 3012184077
- 2028253
- 3010694026
- 1222630
- 3031238386
- 3014601569
- 3018455773
- 3009286597
- 3004126239
- 9680425
- 2424387
- 3010894709
- 3011539161
- 3008959444
- 3009955851
- 3014977697
- 3017103444
- 3017936974
- 3012289707
- 3004116008
- 3010201075
- 3011413020
- 3021635975
- 3018383120
- 3012365608
- 3016910466
- 3027321925
- 3009155917
- 3012386142
- 3033511104
- 3009437400
- 1531264
- 3009942828
- 3018109879
- 3009557417
- 3012316249
- 3010308146
- 3011654863
- 2110420
- 3008902816
- 3014542717
- 3019849074
- 3004727093
- 3013787796
- 3015228371
- 3017150671
- 3013733364
- 3016452327
- 3011191255
- 9611425
- 3016969935
- 3014386328
- 3016746289
- 3023215120
- 3037609256
- 3014834638
- 3012651177
- 3021594313
- 3023326918
- 3033715779
- 3015907115
Source Documents#
Other 510(k) Records For Product Code IRP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2026-05-05 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-04-30 |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-03 |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-02 |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | 2026-01-28 |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. | 2025-11-13 |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | 2025-10-30 |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025-10-24 |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 2025-09-18 |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-09-17 |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-07-25 |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. | 2025-07-23 |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | 2025-05-05 |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | 2025-04-25 |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | 2025-03-17 |
Legacy Summary#
summary
FDA Review#
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